· An article by Tobias Bystry

Food products are no longer expected merely to satisfy hunger or quench thirst; they are also supposed to make consumers healthier, more beautiful and more productive. Health aspects of food products play an increasingly important role in their successful promotion and marketing. The modern consumer eats and drinks with health in mind. Understandably, many food startups want to exploit this trend by creating new products that better cater to the health needs of consumers.

However, both at national and international level, high requirements are placed on food law. This includes the Health Claims Regulation (HCVO, EU Regulation No. 1924/2006) which entered into force in 2007, which regulates nutrition and health claims in the labelling, presentation and advertising of food products in all EU member states. The aim of the Health Claims Regulation is to curb the "proliferation" of health promises and to create a high level of protection for consumers. Anyone who wants to draw attention to how healthy their own products are and does not want to risk a cease-and-desist notice should therefore engage closely with the provisions of the Health Claims Regulation.

In the following article we have therefore summarised, particularly for food startups and manufacturers and retailers of food products, what must fundamentally be observed in food advertising with health references in order to behave in a legally compliant manner.

1. What are health claims within the meaning of the Health Claims Regulation?

"Health claim" means, according to the literal translation, a health-related statement. Art. 2 para. 2 no. 5 of the HCVO defines a "health claim" as follows:

"any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health."

A health claim therefore advertises a health-promoting effect of a food product (this includes food supplements), whereby the underlying concept of health also encompasses mental equilibrium (cf. BGH, judgment of 24.7.2014 – I ZR 221/12 – Original Bach-Blüten).

In addition to specific health-related claims, which are to be assumed as soon as reference is made to specific functions of the body to be promoted, non-specific health-related claims also fall under the general term of health-related claims within the meaning of the HCVO (cf. Art. 10 para. 3 HCVO). A reference to general, non-specific benefits for health or health-related well-being within the meaning of the HCVO is to be assumed where benefits of the food product (or nutrient) are indicated without specifying concrete effects for specific bodily functions.

Health-related, for example, are statements such as "Strengthens the immune system", "Promotes performance", "For strong bones", "Supports metabolism" or "Lowers cholesterol levels".

Contrary to the wording, the scope of the Health Claims Regulation also covers nutrition-related claims. Nutrition-related claims are statements or representations on food packaging or in advertising that convey that a product has a particular nutritional value, thereby increasing the value of the food product in terms of nutrition.

A high nutrient content is frequently advertised, such as "rich in calcium", "high in protein" or "source of fibre". But a low nutrient content can also have a health benefit, for example in the case of fat or sugar (e.g. "low carb", "Low Carb" or "reduced fat").

A "claim" within the meaning of the HCVO is under Article 2 para. 2 no. 1 any statement or representation:

  • that is not obligatory under Community law or national provisions, including representations by images, graphic elements or symbols in any form, and
  • with which it is stated, suggested or even only indirectly expressed that a food product (or food supplement) has special properties.

The term "claim" is therefore to be interpreted very broadly. The claim can be made both in writing and orally; images are also considered claims. Thus, statements made, for example, via the internet, television, radio, etc. can be "claims" within the meaning of the HCVO.

Decisive for the existence of a claim within the meaning of the HCVO is furthermore that statements are made or representations given that can create the impression in a normally informed and reasonably attentive and intelligent average consumer that a food product has special properties (cf. ECJ, judgment of 18.7.2013, C-299/12, para. 24 – Green Swan Pharmaceuticals). From when a claim falling under the HCVO exists is to be answered on a case-by-case basis.

Nutrition or health-related claims do not include in particular generally customary advertising exaggerations. Advertising claims according to which an energy drink gives you wings, fruit gummies make children happy or no yoghurt is more exciting are not subject to the HCVO. General designations traditionally used to indicate a property of a category of food products that could affect human health (such as "throat lozenge") are also excluded. Furthermore, the Federal Court of Justice did not see a nutrition-related claim in the product name "Energy & Vodka", but rather the descriptive statement that it is a mixed drink made of vodka and an energy drink (cf. BGH, judgment of 09.10.2014, I ZR 167/12).

2. What does the Health Claims Regulation regulate and when does it apply?

The Health Claims Regulation (EU Regulation No. 1924/2006) was adopted by the European legislator as long ago as 2006. The Regulation pursues two main objectives:

  • On the one hand, a high level of consumer protection is to be ensured. This means that "health promises" are only permissible if they can also be kept.
  • On the other hand, a uniformly applicable regulation throughout Europe is to ensure the free movement of goods by applying equal competitive conditions. Conversely, however, the Regulation also creates legal certainty for companies.

The Health Claims Regulation therefore applies to nutrition and health-related claims that are made in commercial communications in the labelling, presentation or advertising of food products and food supplements intended to be delivered as such to the end consumer (Art. 1 para. 2 HCVO) and regulates the permissibility of such claims. Under Art. 1 para. 3 HCVO, the Regulation also applies to trade marks, other brand names and fancy names that can be interpreted as nutrition or health-related claims. Furthermore, the Regulation also applies to statements about the reduction of disease risks and to those relating to children.

Important: The Health Claims Regulation only regulates the voluntary area of health-related advertising for food products. The Regulation does not apply to all statements that must be made compulsorily on food products pursuant to a law (e.g. under the Food Labelling Regulation). Only when manufacturers and retailers want to add an additional positive advertising message to their food products that focuses on the particular health benefit do they have to observe the Health Claims Regulation.

Health claims must also be distinguished in particular from therapeutic claims. If a manufacturer advertises that their product can cure or prevent diseases or other ailments, they are a provider of remedies and no longer (only) of food or food supplements. In that case, the Health Claims Regulation does not apply. What must then be observed in particular is the Medicinal Products Advertising Act (HWG).

3. List of permissible health claims

The European Commission tasked the European Food Safety Authority (EFSA) with examining what lies behind advertising slogans and which of the health promises are actually true. On this basis, the EU Commission drew up a list of permissible health-related statements. The list is intended on the one hand to simplify the monitoring of the statements used and on the other hand to prevent companies from creating an intransparent broad field of health claims with ever-new statements that carries the risk of arbitrary use and consumer deception. Health claims are therefore only permitted if their content has been previously reviewed and subsequently included in authorisation lists. Only claims from these lists are permissible. The statements should always display the wording listed, but are probably also permissible if they are equivalent in meaning to the standardised wording (cf. recital 9 HCVO). Companies are furthermore free to apply for the authorisation of further claims through an administrative procedure.

A partial list of the permissible health-related claims (in German) can be found in the Annex to EU Authorisation Regulation No. 432/2012. The list can also be accessed on the EU Commission website. Under Art. 20 para. 1 HCVO, the Commission is obliged to create and maintain an EU register of nutrition and health-related claims about food products. Since Regulation No. 432/2012 has since been expanded and amended by various legislative acts, the EU database should therefore always be accessed for reasons of currency in order to ascertain the authorisation of a health-related claim with legal certainty. Only in the register of the EU Commission are all authorised health claims from all initiative and amending regulations as well as the conditions for their use listed in full. The register also contains a list of rejected health-related claims and the reasons for their rejection.

According to the list, the following statements are permissible, among others:

*- "Magnesium contributes to a reduction in tiredness and fatigue.";

  • "Iron has a function in cell division.";
  • "Vitamin C increases iron absorption.";
  • "Water contributes to the maintenance of normal physical and cognitive functions.";
  • "Zinc contributes to the maintenance of normal nails." and
  • "Sugar-free chewing gum contributes to the maintenance of tooth mineralisation."*

All statements are, however, subject to further conditions, which can also be found in the Annex to the Regulation or in the EU database. Thus the above statement on water is only permissible if the consumer is simultaneously informed that at least 2.0 l of water should be consumed daily in order to achieve the stated effect.

4. Health claims – what is permitted?

a) General requirements

In general, the use of nutrition and health-related claims for food products under Art. 5 HCVO is only permissible if:

  • the stated effect is generally accepted and scientifically proven
  • the substance mentioned is present in the product in sufficient quantity (or not present) to achieve the claimed effect
  • the substance mentioned is in a form that is available to the body
  • the usual amount of the product consumed is suitable to achieve the stated effect
  • the claim relates to the food product ready for consumption.

These requirements must be cumulatively met for a nutrition and health-related claim.

Under Art. 3 HCVO, the nutrition and health-related claims used must in particular not:

  • be false, ambiguous or misleading;
  • give rise to doubt about the safety and/or nutritional adequacy of other food products;
  • encourage or present favourably excessive consumption of a food product;
  • state, suggest or even only indirectly express that a balanced and varied diet cannot generally provide adequate quantities of nutrients.
  • refer – through a textual statement or through representations in the form of images, graphic elements or symbolic representations – to changes in body functions that could arouse fear in or exploit the fears of consumers.

Important: Compliance with the aforementioned conditions alone does not lead to the permissibility of health claims. The Regulation is overall designed as a prohibition with a reservation of permission. Nutrition-related claims must be expressly authorised under an Annex to the HCVO. Health-related claims must appear on the list of authorised claims of the EU Commission (more on this immediately below).

b) Nutritional profiles

Under Art. 4 HCVO, the Commission is to establish specific nutritional profiles for food products (categories), compliance with which is to constitute a further admissibility requirement for nutrition and health-related claims. Only if a food product meets its nutritional profile may health or nutrition-related statements be made at all (apart from a few exceptions, see below). Nutritional profiles are intended to prevent "unhealthy" food products from being advertised with such statements, thereby giving the impression that they have a higher nutritional value than is actually the case. Due to the absence so far of the adoption of relevant nutritional profiles, these are (as yet) not to be observed when using claims under the HCVO (as of January 2024).

Article 4 para. 3 HCVO does, however, also establish a nutritional profile inherent in the Regulation and prohibits health-related claims for alcoholic beverages with an alcohol content of more than 1.2% by volume. In addition, for beverages with an alcohol content of more than 1.2% by volume, only nutrition-related claims are permissible that relate to a low alcohol content or a reduction of the alcohol content or a reduction of energy value (relative prohibition for nutrition-related claims).

Under Article 8 para. 1 HCVO, nutrition-related claims may only be made if

  • they are listed in the list in the Annex to the Regulation and
  • they comply with the general conditions laid down in the Regulation (see above).

In addition to a list for the permissible health claims, there is therefore also a list for the permissible nutrition-related claims. This list contained in the Annex to the HCVO is mandatory for nutrition-related claims (in addition to the general conditions). The list does not prescribe an express formulation for nutrition-related claims, but regulates for certain statement contents the respective material permissibility framework. All claims that are identical to the respective heading (e.g. "low fat", "sugar-free" or "low sodium") or likely to be equivalent in meaning according to consumer understanding must comply with the stated criteria.

For nutrition-related claims, the Health Claims Regulation provides, among other things, for the following:

  • Products described as "energy-reduced" must contain at least 30% less energy than comparable food products.
  • The designation "light" or "lite" has the same meaning as "reduced", i.e. at least 30% less energy or nutrient content.
  • The claim "low fat" is only permissible if the product contains less than 1.5 g of fat per 100 g or 100 ml.

These and other nutrition-related claims such as "high protein content", "high vitamin C content" are listed as binding definitions for 24 different nutrition claims in the Annex to the Regulation.

For health-related claims, the so-called prohibition principle with a reservation of permission applies. Under this principle, health-related claims are in principle prohibited unless they

  • comply with the general principles regulated in Arts. 3 to 7 HCVO (see above) and
  • the specific requirements for health-related claims laid down in Arts. 10 to 19 HCVO and
  • are authorised under the Regulation and included in the list of authorised claims under Arts. 13 and 14 HCVO.

The catalogue of Art. 10 para. 2 HCVO with certain notification obligations is an own admissibility condition for the health-related claim. It requires that the labelling or advertising of a food product contains the following information:

  • a reference to the importance of a varied and balanced diet and a healthy lifestyle,
  • information on the quantity of the food product and the pattern of consumption that are required to achieve the claimed beneficial effect,
  • where applicable, a reference to persons who should avoid consuming this food product, and
  • an appropriate warning notice for products that could pose a health risk if consumed excessively.

The notification obligations must be cumulatively met; violations lead to the impermissibility of the health-related claim.

It must also be noted that health-related claims can change because, for example, research discovers new effects of food products or refutes previously held beliefs.

Furthermore, it must be noted that under Art. 10 para. 3 HCVO, references to general, non-specific benefits of a nutrient or food product for health in general or health-related well-being are only permissible if they are accompanied by a specific health-related claim contained in the lists under Art. 13 or Art. 14 HCVO. The completeness of the lists is no longer required by the case law of the Federal Court of Justice for the application of the provision (cf. BGH, judgment of 19.9.2019 – I ZR 91/18 – Gelenknahrung). The notification obligations of Art. 10 para. 2 HCVO also apply to non-specific health-related claims (cf. BGH, judgment of 12.2.2015 – ref. I ZR 36/11 – Monsterbacke II). This means that such claims are impermissible if they are not combined with the mandatory information.

Many German courts have already dealt with the issue of health-related advertising claims and had to decide which promises are permissible and which are not. The following advertising claims, which were commonly used until recently, were for example found to be impermissible:

As already stated, the provisions of the Health Claims Regulation also extend to statements about the reduction of disease risks and to those relating to children.

The so-called "risk reduction claims" (e.g. "the risk of colds is reduced") are claims according to which the food product or a constituent significantly reduces a risk factor for the development of a disease in humans. Such claims are only permitted if they have been authorised in a specially provided Community list following an official approval procedure. Risk reduction claims must be applied for by the manufacturers who wish to use them, together with submission of scientific data on their truth. The EFSA examines whether the statements are scientifically correct and proposes to the EU Commission the acceptance or rejection of the health claims. Lists of the hitherto permissible claims can be found in EU Regulation No. 1226/2014 and EU Regulation No. 1228/2014.

The following disease-related statement is permissible, for example:

"The use of unsaturated fatty acids instead of saturated fatty acids in the diet has been proven to lower/reduce blood cholesterol levels. High cholesterol is one of the risk factors for coronary heart disease."

This claim may only be used for fats and oils.

In addition to the obligation to authorise the claims, when using disease-reducing claims, additional notification obligations under Art. 14 para. 2 HCVO must also be complied with.

For claims about the development and health of children (e.g. claims "learning-enhancing" and "with iron … to support concentration" for a children's juice), an express authorisation within the framework of the individual authorisation procedure (see above) is also necessary.

6. Checklist – advertising with health claims in food law

In simplified form, the following checklist can ultimately be used to check whether a claim can be used or not:

  1. Is the product to be advertised a food product?
  2. Does the food product meet the nutritional profile? (Due to the absence so far of the adoption of relevant nutritional profiles, this point is not yet to be observed when using claims under the HCVO)
  3. Is the claim health- or nutrition-related, disease-related or about the development and health of children?
  4. Is the health claim permissible in the individual case?
  • for nutrition-related claims: does the claim comply with the Annex to the Regulation?
  • for health-related claims: is the claim on the Community list and does it comply with its requirements?

If these points are answered in the affirmative, the most important hurdles of the Health Claims Regulation have been cleared and the claim may be used if it also complies with the remaining provisions of the Regulation, which should regularly be the case for the "usual" statements on food products.

Impermissible health or nutrition-related claims constitute not only a violation of the Health Claims Regulation, but at the same time a competition violation, since they involve a regulation of market conduct (cf. BGH, judgment of 26.2.2014 – I ZR 178/12).

The rules of the market are laid down in the Act against Unfair Competition (UWG). The UWG regulates the market conduct of competitors in order to secure a free and fair market. Under § 3a UWG, unfair conduct exists where a statutory provision regulating market conduct to protect the interests of market participants is not observed. In the event of a violation of the Health Claims Regulation, competitors as well as certain associations and institutions (cf. § 8 para. 3 UWG) therefore have an injunction claim against the manufacturer and/or retailer who advertises their products with the impermissible health or nutrition-related claims. Legal enforcement is generally first pursued by way of a competition law cease-and-desist notice and, in the event that the demanded cease-and-desist undertaking is not given, then with the help of the courts.

The risk for manufacturers and distributors of food products of being served with a cease-and-desist notice or even receiving a preliminary injunction for a competition violation against the Health Claims Regulation is very high, particularly in times of booming online trade. Online retailers who either adopt the manufacturer's advertising claim for the product or wish to advertise the product with their own claim must also bear in mind that the advertiser bears the burden of explanation and proof for a health-promoting property of a product if this is not listed in the HCVO.

Retailers should therefore be careful with health-related claims and have the product advertising reviewed in advance by an attorney specialising in competition law. This can usually prevent cost-intensive cease-and-desist notices, preliminary injunctions and actions.

If a cease-and-desist notice has already been issued, it is inadvisable to sign the cease-and-desist undertaking enclosed by the parties issuing the notice in the prescribed form without examination, as this is often too broadly worded, so that signing it can have far-reaching consequences, in particular high contractual penalties. Payment claims should also not be fulfilled without having them reviewed by a specialist attorney for competition law. In many cases where the parties issuing the notice are represented by attorneys, the dispute values set are far too high. Here, a reduction in the costs demanded can often be achieved by way of settlement.

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